Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients

NCT05384574 | Unknown

• 1 other identifier: 2181-147/01/06/M.S.-21-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Single center, open label randomized clinical trial. Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study. Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (\<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test. Intervention: All patients included in this study will receive standard of care. Patients randomized into intervention group will be receiving 10 000 IU of cholecalciferol daily. Supplement will be administered orally or via gastric tube during ICU stay or for at least 14 days in case of ICU discharge before day 14. Supplementation will begin within 48 hours of admission to ICU. Supplement will be prepared and administered by experienced nursing staff. For patients receiving supplementation, vitamin D levels will be checked on days 7 and 14. In case that vitamin D levels are \> 150 nmol/l or if the calcium levels are consistently \> 2.6 mmol/l, further supplementation will be stopped. Outcomes: Primary outcome is number of days spent on ventilator. Secondary outcomes: all-cause mortality on day 28, all-cause mortality on day 60, mortality at hospital discharge, clinical improvement at day 28 (WHO clinical progression scale), days spent in ICU, days spent in hospital after discharge from ICU, need for dialysis at day 28, bacterial superinfections, neutrophile to lymphocyte ratio, disease severity (CRP levels, PaO2/FiO2 ratio, D-dimer levels, fibrinogen, ferritin, PCT), adverse outcomes. Hypothesis: patients receiving Vitamin D supplementation will have shorter number of days spent on mechanical ventilation.

Conditions

Covid-19; Respiratory Distress Syndrome; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• number of days on mechanical ventilation

  Number of days spent on mechanical ventilation for each patient

  Daily, through study completion, on average 6 months

Secondary Outcomes (12)

• All-cause mortality on day 28

  day 28

• All-cause mortality on day 60

  day 60

• clinical improvement at day 28

  day 28

• Number of days spent in ICU

  Daily, through study completion, on average 6 months

• Number of days spent in hospital after ICU discharge

  Daily, through study completion, on average 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Patients with low levels of Vitamin D on admission to ICU randomized to receive vitamin D supplementation

Dietary Supplement: cholecalciferol

Control

NO INTERVENTION

Patients with low levels of Vitamin D on admission to ICU not receiving vitamin D supplementation

Interventions

cholecalciferol DIETARY_SUPPLEMENT

daily supplementation of cholecalciferol, 10 000 IU, during 14 days

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (\<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.

You may not qualify if:

• Patients will be excluded from study in case of calcium levels that are consistently above normal serum range (\> 2.6 mmol/L, \> 10.5 mg/dL) or if vitamin D levels are \> 150 nmol/L.

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital Split

Split, 21000, Croatia

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Lenko Saric, M.D. PhD

  University Hospital Split, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Intensive Care specialist

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 20, 2022
• Study Start: November 22, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)